Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy

NCT03453866 | Completed

• 1 other identifier: 17-2399
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes post-operatively in the warmed fluid group compared to the control group. Secondary outcome measures to be collected will include VAS scores 60 minutes after surgery and on post-operative day (POD) one. Additionally, the investigators will collect post-operative temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing in PACU and at the two-week follow up visit.

Conditions

Femoro Acetabular Impingement; Pain, Postoperative

Keywords

Hip Arthroscopy; Warmed Fluids

Outcome Measures

Primary Outcomes (1)

• Changes in Visual Analog Score

  A Visual Analog Score (VAS) will be measured pre-operatively, 30 and 60 minutes after patient arrival in the post-anesthesia care unit (PACU). Additionally, VAS will be collected in the clinic on post-operative day (POD) 1 and POD 14. The visual analog scale measures subject reported pain on a scale of 0-100 with a score of 0 indicating no pain and 100 indicating the worst pain possible.

  Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.

Secondary Outcomes (2)

• Changes in Temperature

  30-60 minutes after after completion of surgery

• Morphine Equivalent Dosage (MED)

  After completion of surgery and at the 2-week Post Operative Visit

Other Outcomes (2)

• Hip Outcomes Score (HOS)

  Pre-operatively

• Veterans Rand 12 (VR-12)

  Pre-Operatively

Study Arms (2)

Warmed Arthroscopic Fluids

EXPERIMENTAL

Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.

Procedure: Warmed Arthroscopic Fluids

Room Temperature Arthroscopic Fluids

ACTIVE COMPARATOR

Arthroscopic fluids will be kept at room temperature and will not be warmed per current standard of care. Temperature will be measured in real time.

Procedure: Room Temperature Arthroscopic Fluids

Interventions

Warmed Arthroscopic Fluids PROCEDURE

Warmed Arthroscopic Fluids

Warmed Arthroscopic Fluids

Room Temperature Arthroscopic Fluids PROCEDURE

Room Temperature Arthroscopic Fluids

Room Temperature Arthroscopic Fluids

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18-65 years with a confirmed diagnosis of Femoroacetabular impingement (FAI)
• Required hip arthroscopy will be considered for the study
• Pre-operative history and physical exam
• Magnetic resonance imaging (MRI) before being indicated for arthroscopic surgery

You may not qualify if:

• Taking narcotic medications at baseline
• Have a history of complex regional pain syndrome,
• Have hip arthritis,
• Have undergone previous hip arthroscopic surgery, or
• Are deemed incapable by the Principal Investigator of completing the study.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Steadman Hawkins Clinic, University of Colorado Denver

Englewood, Colorado, 80112, United States

Location

Related Publications (5)

• Truntzer JN, Shapiro LM, Hoppe DJ, Abrams GD, Safran MR. Hip arthroscopy in the United States: an update following coding changes in 2011. J Hip Preserv Surg. 2017 Mar 23;4(3):250-257. doi: 10.1093/jhps/hnx004. eCollection 2017 Aug.

  PMID: 28948037 BACKGROUND

• Stafford GH, Malviya A, Villar RN. Fluid extravasation during hip arthroscopy. Hip Int. 2011 Nov-Dec;21(6):740-3. doi: 10.5301/HIP.2011.8845.

  PMID: 22117260 BACKGROUND

• Steelman VM, Chae S, Duff J, Anderson MJ, Zaidi A. Warming of Irrigation Fluids for Prevention of Perioperative Hypothermia During Arthroscopy: A Systematic Review and Meta-analysis. Arthroscopy. 2018 Mar;34(3):930-942.e2. doi: 10.1016/j.arthro.2017.09.024. Epub 2017 Dec 6.

  PMID: 29217304 BACKGROUND

• Ousey K, Edward KL, Lui S, Stephenson J, Walker K, Duff J, Leaper D. Perioperative, local and systemic warming in surgical site infection: a systematic review and meta-analysis. J Wound Care. 2017 Nov 2;26(11):614-624. doi: 10.12968/jowc.2017.26.11.614.

  PMID: 29131754 BACKGROUND

• Benson EE, McMillan DE, Ong B. The effects of active warming on patient temperature and pain after total knee arthroplasty. Am J Nurs. 2012 May;112(5):26-33; quiz 34, 42. doi: 10.1097/01.NAJ.0000414315.41460.bf.

  PMID: 22546733 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement; Pain, Postoperative

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• James Genuario, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sealed Opaque Envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 5, 2018
• Study Start: February 9, 2018
• Primary Completion: August 1, 2021
• Study Completion: September 20, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)